GUEST COLUMNISTS

• System Impact Assessment: A Risk Management Framework For A COVID World

  Infusing risk management is essential to an organization, especially in terms of facility, utility, and equipment qualification. Although qualification is usually the last step before moving to process characterization and validation, integrating a risk management approach is an effective way to ensure qualification activities are focusing on what matters most — that equipment performs as expected.

• Understanding the Three Major Challenges Limiting Innovation In Tissue Engineering

  The regenerative medicine sector, comprised of tissue engineered products and cell and gene therapies, has grown rapidly over the past decade, including significant therapeutic advances that offer the prospect of optimizing and transforming patient care. There has been a dramatic increase in the number of approved cell and gene therapies and available funding for these products, and yet both progress in development programs and approvals for tissue engineered medical products (TEMPs) have lagged behind.

• New Approaches In Patient Tracking For The Rare Disease Sector

  While we have seen exponential growth in the effort to develop drugs to treat rare diseases in the 30 years since the Orphan Drug Act was introduced, unique challenges remain. Awareness of rare diseases is often low among stakeholders including physicians, healthcare providers, payers, and even patients themselves; trial protocols and regulatory pathways may be unclear, especially for investigational rare disease drugs that are first-in-class; and data on disease incidence, onset, progression, and burden are often limited.

• Moving Beyond Human Error In Biopharma Investigations And CAPA Programs

  Human performance improvement requires special focus and deliberate action by management to move from an old construct of investigating error as a human failure to an new construct where error is a symptom of a problem to be understood, linked to the context in which the error took place, and it is the starting point of the investigation, not its conclusion.

• Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products

  This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"

• Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity

  Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants. 

• Pandemic Accelerates Expanding Role Of Real-World Evidence In FDA Medical Device Submissions

  By forcing the FDA to become comfortable with the use of real-world data in order to authorize COVID-19 diagnostic tests, the pandemic may have unintentionally forced the agency to reflect in a more pragmatic way on what characteristics of real-world evidence (RWE) it believes are essential for data integrity and what level of uncertainty it can tolerate in connection with RWE.

• How EMD Serono Is Bringing Diverse Patient Voices Together

  The pandemic has created an opportunity to address some of the causes underlying clinical care inequities. And while combatting these issues will take time, much can be done by first addressing the gap for minorities in clinical trials. This is a topic I am passionate about both personally and professionally as a female Hispanic chief medical officer.